Can you accept the EVAR Trials 10-year results and still justify - - PowerPoint PPT Presentation

Can you accept the EVAR Trials 10-year results and still justify EVAR for all-comers?

Janet Powell Imperial College London

Questions to be addressed

 What did the analyses show?  Is continued enthusiasm for EVAR technology justified if we accept this high quality evidence?  Is there a place for patient selection based on risk assessment?

The EVAR randomised trials for elective AAA repair All had selective recruitment: not all-comers

Predated widespread screening, so large AAAs EVAR

AAA diameter ≥5 or 5.5cm Fit for either treatment Within IFU Age 50+ year, ~90% men Recruiting 1999-2008

Open repair

4 trials In Europe/USA EVAR-1 OVER DREAM ACE EVAR-2

AAA ≥ 5,5cm Unfit for open repair Within IFU Randomised to early EVAR

• r no intervention

The EVAR 2 trial for those unfit for open repair

20 40 60 80 100 207 137 80 51 38 25 15 No repair 197 127 81 59 31 18 6 Endovascular repair Number at risk 2 4 6 8 10 12 Years since Randomization

EVAR No intervention

Aneurysm-related mortality

EVAR No intervention

All-cause mortality

HR = 0.46; p=0.019 HR = 1.07; p=0.52

• Lower aneurysm-related mortality: HR=0.46; p=0.02
• No benefit in terms of total mortality: HR=1.07; p=0.52
• 7% survival probability at 12-years
• Unfit patients, never any survival benefit from EVAR: cost burden

Open EVAR

The EVAR 1 trial of EVAR vs open repair in fit patients within IFU: Survival over 15 years

AAA-related mortality Lancet 2016

20 40 60 80 100 Percentage Surviving 626 534 464 399 333 257 143 50 Open repair 626 543 474 409 339 263 135 41 Endovascular repair Number at risk 2 4 6 8 10 12 14 Years since Randomization

Endovascular-repair aneurysm-related survival, 0.830 (0.762, 0.880) Open-repair aneurysm-related survival, 0.879 (0.764, 0.940) Endovascular-repair survival from any cause, 0.148 (0.103, 0.199) Open-repair survival from any cause, 0.238 (0.194, 0.284)

Showed the same & more reinterventions in EVAR group

Decreasing cost-effectiveness of EVAR vs open repair after 10 years: why?

• Increasing mortality NASTY

Increased secondary rupture & aneurysm-related mortality Increased risk of abdominal cancer & deaths from cancer

• Increasing costs NASTY

More surveillance & increasing numbers of re-interventions After 10 years <50% patients remain alive

The fading promise of EVAR: blamed on old technology Unlikely

Device modifications have extended EVAR-eligibility: no guarantee newer devices will perform better: NASTY!

• Lifetime of devices needs to be 20 years
• Increasing use of low profile devices: the fabric is subject to compression-

induced crimping & wrinkling: increased risk of tears & porosity

• Despite improvements in the purity of nitinol, supports still liable to

fractures with time But, better imaging should allow for more accurate placement

2 Unsolved or insoluble contributors to EVAR failure NASTY

Proximal seal in regions of unidentified aortic disease Progression of aneurysmal disease over time Poor compliance with surveillance

Who wants EVAR? 2 Is there still enthusiasm for EVAR?

Patients Clinicians Industry √√√ √√ √√√√ EVAR is here to stay So it has to get better, with appropriate patient selection

Precision medicine, for patients exiting NAAASP 3 Treatment based on risk assessment

68 years, married AAA 5.6 cm Sedentary lifestyle Smoker, recent MI Morphology not quite IFU 75 years, married AAA 5.5 cm Keen golfer Morphology within IFU Compliant with BP drugs 74 years, divorced AAA now 6.3 cm Emigrating to Spain? Morphology close to IFU Defaulted from surveillance

Defer Open repair EVAR

Although EVAR cannot be justified in all-comers, there is a future for EVAR

• Learn from history
• Careful selection of fit patients
• Address the NASTY issues
• Better devices

Non-metallic fixation, more applicable to women, more durable, inbuilt sensors for early remote warning of problems